ISO 13485 Quality Management System for medical devices

ISO 13485 provides a practical foundation for medical device companies to address medical device quality directives, regulations and responsibilities resulting a commitment to the safety and quality of medical device products.

In today’s competitive business environment operating internationally or expanding locally, companies with an ISO 13485 certification communicate a quality commitment to both customers and regulators. It allows increasing access to more markets worldwide, provides a mechanism on how to review processes across your organization for continuous improvement, and can increase efficiency, cut costs and improve your supply chain performance.


Arica CQ

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